Implant with intramedullary portion and offset extramedullary portion

ABSTRACT

An implant comprises a unitary body including an intramedullary portion connected to an extramedullary portion. The unitary body is configured to attach a first bone section to a second bone section. The intramedullary portion has a first longitudinal axis, and is configured for insertion into the first bone section. The intramedullary portion includes at least one first fastener aperture having an aperture axis oriented obliquely relative to the first longitudinal axis. The extramedullary portion is configured to abut a surface of the second bone section and includes at least one second fastener aperture disposed to transversely receive a bone fastener inserted in the second bone section. The extramedullary portion has a second longitudinal axis offset from, the first longitudinal axis.

This application claims the benefit of U.S. Provisional Application No.62/578,046, filed Oct. 27, 2017, which is expressly incorporated byreference herein in its entirety.

FIELD

This disclosure relates generally to medical devices, and morespecifically to implants for correcting bone deformity.

BACKGROUND

Hallux valgus deformities in the human foot relate to a condition inwhich the first (great) toe has a deviated position leaning in towardsthe second toe. The first metatarsal deviates towards the mid-sagittalplane, and the great toe deviates away from the mid-sagittal plane. Thisis often accompanied by a bump due to a swollen bursal sac or a bonyanomaly on the metatarsophalangeal joint.

A variety of non-surgical methods are used to treat hallux valgus, butin cases of continued pain or visible deformity, the patient may seek asurgical correction of the condition. Surgical methods may includeremoving the bony enlargement of the first metatarsal, realigning thefirst metatarsal bone relative to the adjacent metatarsal bone, and/orstraightening the great toe relative to the first metatarsal andadjacent toes. Such surgical methods may result in visible scarring.

SUMMARY

In some embodiments, an implant comprises a unitary body including anintramedullary portion connected to an extramedullary portion. Theunitary body is configured to attach a first bone section to a secondbone section. The intramedullary portion has a first longitudinal axis,and is configured for insertion into the first bone section. Theintramedullary portion includes at least one first fastener aperturehaving an aperture axis oriented obliquely relative to the firstlongitudinal axis. The extramedullary portion is configured to abut asurface of the second bone section and includes at least one secondfastener aperture disposed to transversely receive a bone fastenerinserted in the second bone section. The extramedullary portion has asecond longitudinal axis offset from, the first longitudinal axis.

In some embodiments, an implant system, comprises a nail, screw, k-wireor rod, and an implant. The implant comprises a unitary body includingan intramedullary portion connected to an extramedullary portion. Theunitary body is configured to attach a first bone section to a secondbone section. The intramedullary portion has a first longitudinal axis,and is configured for insertion into the first bone section. Theintramedullary portion includes at least one first fastener aperturehaving an aperture axis oriented obliquely relative to the firstlongitudinal axis and adapted to receive the nail, screw, k-wire or rod.The extramedullary portion is configured to abut a surface of the secondbone section and includes at least one second fastener aperture disposedto transversely receive a bone fastener inserted in the second bonesection. The extramedullary portion has a second longitudinal axisoffset from, the first longitudinal axis.

In some embodiments, a method of treating a hallux valgus comprises:

performing an osteotomy in a bone to separate a distal section of thebone from a proximal section of the bone; forming a longitudinal hole inthe proximal section of the bone; inserting an intramedullary portion ofan implant into the longitudinal hole, the intramedullary portion havinga first longitudinal axis and a first aperture, the first aperturehaving an aperture axis oriented at an oblique angle with respect to thefirst longitudinal axis, the implant having an extramedullary portionconnected to the intramedullary portion, the extramedullary portionhaving a second longitudinal axis offset from the first longitudinalaxis, the extramedullary portion having at least one distal aperture;drilling an inter-fragment hole, through the proximal section and thefirst aperture, and into the distal section; inserting a fastenerthrough the distal aperture and into the distal section to attach theextramedullary portion to the distal section with a nearest medial edgeof the distal section offset from the first longitudinal axis; andinserting a nail, screw, k-wire or rod through the proximal section andthe first aperture, and into the inter-fragment hole.

In some embodiments, a target guide comprises a threaded portion adaptedto engage a fastener aperture of an implant having an implantlongitudinal axis. A body is movable with the threaded portion. The bodyis adapted to extend from a portion of the implant defining the fasteneraperture when the threaded portion engages the fastener aperture. Thetarget guide is adapted to apply a moment to rotate the implant aroundthe implant longitudinal axis when a force is applied to the body, or ak-wire or drill extending from the body. The target guide has a passagepenetrating the body and adapted for targeting a first drill fordrilling a hole in a first bone section.

In some embodiments, an implant system comprises a nail, screw, k-wireor rod, an implant, and a target guide. The implant comprises a unitarybody including an intramedullary portion connected to an extramedullaryportion. The unitary body is configured to attach a first bone sectionto a second bone section. The intramedullary portion has a firstlongitudinal axis, and is configured for insertion into the first bonesection. The intramedullary portion includes at least one first fasteneraperture having an aperture axis oriented obliquely relative to thefirst longitudinal axis and is adapted to receive the nail, screw,k-wire or rod. The extramedullary portion is configured to abut asurface of the second bone section and including at least one secondfastener aperture disposed to transversely receive a bone fastenerinserted in the second bone section. The extramedullary portion has asecond longitudinal axis offset from, the first longitudinal axis. Thetarget guide has a threaded portion adapted to engage the secondfastener aperture. The target guide has a body adapted to extend fromthe extramedullary portion when the threaded portion engages the secondfastener aperture. The target guide has a central longitudinal passagepenetrating the body and adapted for targeting a drill for drilling ahole in the second bone section.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a lateral view of an exemplary implant according to oneembodiment.

FIG. 2 is a superior view of the exemplary implant of FIG. 1.

FIG. 3 is a cross-sectional view taken along section line 3-3 of FIG. 1.

FIG. 4 is an inferior view of a target guide for use with the implant ofFIG. 1.

FIG. 5 is a medial view of the target guide of FIG. 4.

FIG. 6 is a lateral view of the target guide of FIG. 4.

FIG. 7 is a cross-sectional view of the target guide taken along sectionline 7-7 of FIG. 5.

FIG. 8 is an anterior view of the target guide viewed from line 8-8 ofFIG. 4.

FIG. 9 is a posterior view of the target guide viewed from line 9-9 ofFIG. 4.

FIG. 10 is a side view of a drill guide configured for use with thetarget guide of FIG. 4.

FIG. 11 is a cross-sectional view of the drill guide taken along sectionline 11-11 of FIG. 10.

FIG. 12A is an anterior view of a foot, showing use of the target guideof FIG. 4 as a tool for positioning and rotating the implant of FIG. 1and the distal section of a first metatarsal.

FIG. 12B shows the targeting guide in position for drilling a distalhole and an inter-fragment hole in the first metatarsal of the foot ofFIG. 12A.

FIG. 12C is a flow chart of a method of treatment using the implant ofFIG. 1 and the target guide of FIG. 4.

FIG. 13 shows the first metatarsal of FIG. 12B, after insertion of theimplant.

FIG. 14 is a superior view of an exemplary implant according to oneembodiment.

FIG. 15 is a lateral view of the exemplary implant of FIG. 14.

FIG. 16 is a cross-sectional view taken along section line 16-16 of FIG.15.

FIG. 17 is a superior view of an exemplary implant according to anotherembodiment.

FIG. 18 is a lateral view of the exemplary implant of FIG. 17.

FIG. 19 is a cross-sectional view taken along section line 19-19 of FIG.18.

FIG. 20 is a lateral view of an exemplary implant according to anadditional embodiment.

FIG. 21 is a superior view of the exemplary implant of FIG. 20.

FIG. 22 is a cross-sectional view taken along section line 22-22 of FIG.21.

FIG. 23 is a lateral view of an exemplary implant according to anotherembodiment.

FIG. 24 is a superior view of the exemplary implant of FIG. 23.

FIG. 25 is a cross-sectional view taken along section line 25-25 of FIG.23.

FIG. 26 is a plan view of a broach used for inserting the implant ofFIG. 23.

FIG. 27 is a cross-sectional view taken along section line 27-27 of FIG.26.

FIG. 28 is an enlarged detail of FIG. 27.

FIG. 29 shows use of the broach of FIG. 26 to form an opening in theproximal portion of a metatarsal.

FIG. 30 is a schematic view of the implant of FIG. 23 superimposed onthe broach of FIG. 29 in situ.

FIG. 31 is a superior view of a variation of the targeting guide.

FIG. 32 is a flow chart of a method of using the implant of FIGS. 23-25,the broach of FIGS. 26-30 and the targeting guide of FIG. 31 for aminimally invasive surgery.

DESCRIPTION

This description of the exemplary embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. In the description, relativeterms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,”“below,” “up,” “down,” “top” and “bottom” as well as derivative thereof(e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing under discussion. These relative terms are for convenienceof description and do not require that the apparatus be constructed oroperated in a particular orientation. Terms concerning attachments,coupling and the like, such as “connected” and “interconnected,” referto a relationship wherein structures are secured or attached to oneanother either directly or indirectly through intervening structures, aswell as both movable or rigid attachments or relationships, unlessexpressly described otherwise. In the various drawings, like referencenumerals indicate like items, unless expressly stated otherwise.

This disclosure provides an implant and a target guide for preparing thebones for the surgery, and a treatment method for inserting the implantsuitable for minimally-invasive correction of hallux valgus (or of ananalogous deformity in another joint). Although the drawings showapplication of the implant and target guide to treat a first metatarsalfor correction of hallux valgus, the implant and target guide can besized and configured to treat other bones, and can also be used in avariety of minimally-invasive or open procedures.

FIGS. 1-3 show a first example of the implant 100. FIG. 1 is a plan viewof the implant 100. FIG. 2 is a medial (or lateral) side view of theimplant 100 of FIG. 1. FIG. 3 is a cross-sectional view of the implant100 of FIG. 1, taken along section line 3-3. FIG. 13 shows the implant100 in situ after insertion in the foot 400 of a patient.

Referring to FIGS. 1-3, the implant 100 has a unitary body including anintramedullary portion 110 connected to an extramedullary portion 130.The unitary body of implant 100 is configured to attach a first bonesection 410 (FIG. 13) to a second bone section 412 (FIG. 13). It shouldbe noted that the implant 100 can be used on either left or right foot.

The intramedullary portion 110 has a first longitudinal axis 120, whichcan be a central axis. The intramedullary portion 110 is configured forinsertion into the first bone section 410 (FIG. 13). The intramedullaryportion 110 includes at least one first fastener aperture 112 having anaperture axis 122. In some embodiments, the aperture axis 122 isoriented obliquely relative to the first longitudinal axis 120. In otherembodiments (not shown), the aperture axis 122 is from about 90 degreesto about 180 degrees from the first longitudinal axis. For example, insome embodiments, the aperture axis 122 is oriented orthogonal to thefirst longitudinal axis 120. The at least one first fastener aperture112 is configured to receive a nail, screw, k-wire or rod extendingtherethrough. FIG. 13 shows a screw 450 in the first fastener aperture112; a nail, k-wire or rod can be positioned in the same location in thefirst bone section 410, as shown in FIG. 13.

The extramedullary portion 130 is configured to abut a surface of thesecond bone section 412 (FIG. 13). The extramedullary portion 130includes at least one second (distal) fastener aperture 134 disposed toreceive a bone fastener 452 (e.g., an “Ortholoc® 3Di™” locking screwsold by Wright Medical Technology, Inc. of Memphis, Tenn.), inserted inthe second bone section 412. The bone fastener 452 may be disposedtransversely or obliquely, relative to the fastener aperture 134. Insome embodiments, polyaxial screws can be inserted with an angle of 0.0to about 15 degrees from the transverse axis of the second (distal)fastener aperture 134. In some embodiments, polyaxial screws such as 3Dilocking screws or non-locking screws sold by Wright Medical Technology,Inc. of Memphis, Tenn. may be utilized. The extramedullary portion 130has a second longitudinal axis 121 parallel to, and offset from, thefirst longitudinal axis 120.

The extramedullary portion 130 has a first side 136 facing radiallyinward (opposite the radial direction R) toward the first longitudinalaxis 120 and a second side 138 facing radially outward (in the radialdirection R) away from the first longitudinal axis 120. In someembodiments, the second side 138 has a concave surface adapted to engagea curved bone surface 413.

In some embodiments, the intramedullary portion 110 comprises a cylinderor cylindrical shaft having an outer surface 105, and the extramedullaryportion 130 is joined to the intramedullary portion 110 so that aportion of the outer surface 105 is located between the first side 136of the extramedullary portion 130 and the second side 138 of theextramedullary portion 130. That is, the first side 136 can be locatedradially inward from the surface 105, and the second side 138 can belocated radially outward from the surface 105. The offset 123 betweenthe first longitudinal axis 120 of the intramedullary portion 110 andthe second longitudinal axis 121 of the extramedullary portion 130 canhave a variety of values, each corresponding to a different amount oftranslation (also referred to as “shifting”) of the first bone.

In some embodiments, the intramedullary portion 110 has a taperedproximal end 114. The tapered proximal end 114 facilitates insertion ofthe implant 100 into a longitudinal hole in the first (proximal) section410 of the bone. The intramedullary portion 110 can also have a beveleddistal end 116 to provide a smoother transition between the first bonesection 410 (FIG. 13) and the second bone section 412 (FIG. 13).

The implant 100 can comprise a metal, such as titanium, stainless steel,or CoCr. In some embodiments, the implant 100 can comprise a metalsubstrate coated with or having an additional layer of hydroxyapatite(HA), titanium plasma spray (TPS)/vacuum plasma spray (VPS), roughenedsurface of resorbable blast media (RBM), a bioactive glass, anantimicrobial or antibiotic, or strontium. Alternatively, the implant100 can comprise a metal substrate with a composite coating or compositelayer including HA on plasma, beads, an irregular sintered coating orTPS on an RBM-prepared substrate. In other embodiments, the metalsubstrate can have a porous coating. such as spherical bead,asymmetrical powder or an irregular particle coating.

In some embodiments, the metal substrate of implant 100 comprises adegradable (resorbable) material, such as a magnesium alloy, which maycontain lithium, aluminum, rare earth metals (e.g., neodymium orcerium), manganese, zinc or other metals. In other embodiments, theresorbable material can include, but are not limited to polymermaterials including polyether ether ketone (PEEK), a polylactide,polyglycolide, polycaprolactone, polyvalerolactone, polycarbonates,polyhydroxy butyrates, poly ortho esters, polyurethanes, polyanhydrides,and combinations and copolymers thereof, for example.

In some embodiments, the implant 100 comprises a biologic material. Thebiologic material can be a combination of Medical grade β-TCP granulesand rhPDGF-BB solution, such as “AUGMENT®” bone graft material sold byWright Medical Technology, Inc. of Memphis, Tenn. The biologic materialcan be applied, sprayed, or inserted at the wound site for bonein-growth, or can be provided as a coating on the implants or any or allportions of the implant system. In some embodiments, the biologicmaterial is a coating containing osteoinductive or osteoconductivebiological components. In some embodiments, the biologic material caninclude bone morphogenetic factors, i.e., growth factors whose activityare specific to bone tissue including, but not limited to, demineralizedbone matrix (DBM), bone protein (BP), bone morphogenetic protein (BMP),and mixtures and combinations thereof. Additionally, formulations forpromoting the attachment of endogenous bone may comprise bone marrowaspirate, bone marrow concentrate, and mixtures and combinationsthereof.

FIGS. 4-9 show a target guide 200 suitable for guiding drills to formfastener holes in a bone, for insertion of the implant 100 into thefirst bone section 410 (FIG. 13) and attachment of the second bonesection 412 (FIG. 13). FIG. 4 is a plantar view of the target guide 200(when used for treating the right foot as shown in FIG. 12B), and FIG.12B shows the dorsal side of the target guide 200. FIG. 5 is a medialview of the target guide 200. FIG. 6 is a lateral view of the targetguide 200. FIG. 7 is a cross-sectional view of the target guide 200taken along section line 7-7 of FIG. 5. FIG. 8 is an anterior view ofthe target guide 200. FIG. 9 is a posterior view of the target guide200.

A single target guide 200 can be used for treating hallux valgus in bothright feet and left feet. FIGS. 12A-12B show the target guide 200 in useon a right foot 400, with the side 202 facing in the dorsal direction,and the side 201 facing in the plantar direction. When the target guide200 is used for treating the left foot (not shown), the target guide 200is flipped over, so that the side 201 of the target guide 200 shown inFIG. 4 becomes the dorsal side, and the side 202 shown in FIG. 12Bbecomes the plantar side. The medial, lateral, anterior, and posteriorviews correspond to FIGS. 5, 6, 8, and 9, respectively when treating theleft foot (the same as when treating the right foot).

Referring again to FIGS. 4-9, the target guide 200 has a hollow cylinder230, and a body 240 having threaded portion 244 attached thereto. Thebody 240 is disposed concentrically in the hollow cylinder 230. The body240 has a central longitudinal passage 242 with a central longitudinalaxis 231. The threaded portion 244 is adapted to engage a distalfastener aperture 134 of the implant 100. In some embodiments, thehollow cylinder 230 has a passage 232 and a body 240 in the shape of acollar mounted in the passage 232 of the hollow cylinder 230. Thecentral longitudinal passage 242 is used for guiding a drill to form adistal hole in the distal section 412 of the bone. The body 240 includesthe threaded portion 244 and has an inner cylindrical wall 243 definingthe central longitudinal passage 242. The inner cylindrical wall 243 isconcentric with the passage 232 of the hollow cylinder 230.

The body 240 is concentrically mounted within hollow cylinder 230. Apress-fit pin 245 (FIG. 12A) keeps the body 240 in place, but body 240is freely rotatable within hollow cylinder 230 and this allows thethreaded end 244 of body 240 to thread into the distal fastener hole 134within the extramedullary portion 130 of implant 100.

In some embodiments, the central longitudinal passage 242 is sized toreceive a drill guide, such as a threaded drill guide (not shown). Inother embodiments, the body 240 is itself configured to act as a drillguide, and includes a threaded end, adapted to thread into the distalaperture 134 of the extramedullary portion 130.

As discussed below in the description of FIG. 12A, the body 240 isadapted to extend away from the extramedullary portion 130 defining thedistal fastener aperture 134 of the implant 100, when the threadedportion 244 of body 240 engages the distal fastener aperture 134. Thetarget guide 200 is adapted to apply a moment M to rotate the implant100 around the first longitudinal axis 120 of the implant 100 when aforce F₁ or F₂ is applied to the hollow cylinder 230, body 240 (or ak-wire 251 or drill 250, FIG. 12B, extending through the body 240),where the force F₁ or F₂ is applied in a direction orthogonal to thefirst longitudinal axis 120 of the implant 100 and through the centrallongitudinal axis 231 of the body 240. The central longitudinal axis 231of the body 240 is perpendicular to the first longitudinal axis 120 ofthe intramedullary portion 110, maximizing the length of the moment armMA about axis 120 (FIG. 2) for an external force F₁ or F₂ applied to thehollow cylinder 230 or body 240. Washers or spacers (not shown) can beplaced between the plate 130 and the translated bone segment 412 toincrease the amount of translation.

Referring again to FIGS. 4-9, the target guide 200 further comprises anarm 210 extending from the hollow cylinder 230. The arm 210 has a guideaperture 214 penetrating the arm 210 and adapted for targeting a seconddrill 350 for drilling a second hole (inter-fragment hole) 453 (FIG. 13)through a proximal bone section 410 and into the distal bone section412. In some embodiments, the guide aperture 214 is configured toreceive the drill guide 300 of FIGS. 10 and 11, described below.

The body 240 has a first longitudinal axis 231, and the guide aperture214 of the arm 210 of target guide 200 has a second longitudinal axis215 (FIG. 7). The arm 210 has a third longitudinal axis 217 (FIG. 4),such that a plane passes through the first longitudinal axis 231, secondlongitudinal axis 215, and third longitudinal axis 217. The distalfastener aperture 134 of the extramedullary portion 130 penetrates aninterface surface 125 of the extramedullary portion 130 of the implant100. When the threaded portion 244 of body 240 engages the distalfastener aperture 134 of the implant 100, the longitudinal axis 231 ofthe body 240 is normal to the interface surface 125.

FIGS. 10 and 11 show an example of a drill guide 300 suitable for usewith the target guide 200. FIG. 10 is a plan view of the drill guide300, and FIG. 11 is a cross-section of the drill guide 300, taken alongsection line 11-11 of FIG. 10. FIG. 12B shows the drill guide 300 insitu in the target guide 200.

In FIGS. 10 and 11, the drill guide 300 has an outer surface 310 with anouter diameter 302 sized to be slidably received in the guide aperture214 of target guide 200. The drill guide 300 has a first portion with abore 312 having a first inner diameter 318. The drill guide 300 has asecond portion with a bore 314 having a second inner diameter 320 lessthan the first inner diameter 318. The second inner diameter 320 issized to slidably receive and align a drill 350 (FIG. 12B) thatpenetrates the drill guide 300, the proximal bone section 410, theintramedullary portion 110 of the implant 100, and the distal bonesection 412. The drill 350 forms an inter-fragment hole through theproximal bone section 410 and into the distal bone section 412. Thefirst inner diameter 318 of the bore 312 of drill guide 300 is sizedlarger than the second inner diameter 320, to avoid friction between thedrill 350 and the sidewall of bore 312. The drill guide 300 has a tapersection 316 between (and connecting) the bore 312 and the bore 314, forguiding the drill 350 into the bore 314. The drill guide 300 may alsohave a knob 322 with a larger diameter than the outer surface 310. Theknob 322 acts as a stop to prevent the drill guide 300 from falling outof the arm 210. The knob 322 can have a gripping surface, such asridges, grooves, splines, or a knurled, patterned or textured surface.

FIG. 12A is an anterior view of a foot 400 having a first metatarsal,which has been separated into a proximal section 410 and a distalsection 412. The foot 400 has second, third, fourth and fifthmetatarsals, labeled 413, 414, 415 and 416, respectively. FIG. 12A showsthe target guide 200 being used as a tool to position and rotate theimplant 100 and the second (distal) section 412 of the bone (e.g., firstmetatarsal) about the first longitudinal axis 120 of implant 100 insitu, after the intramedullary portion 110 of implant 100 is inserted ina longitudinal intramedullary hole 414 (FIG. 12B) in the proximalsection 410 of the bone. The distal section 412 and the target guide 200are shown in solid lines to represent the position of the target guide200 and distal section 412 before rotation. The distal section 412 andthe target guide 200 are shown in phantom to represent the position ofthe target guide 200 and distal section 412 after rotation. The force F₁or F₂ is shown as a solid line indicating application of the force F₁ orF₂ to directly to the body 240, and is shown in phantom to show thealternative position for application of the force F₁ or F₂ to the k-wire251 or drill 250. The force F₁ can be applied in the clockwisedirection, or the force F₂ can be applied in the counter-clockwisedirection. The force F can be applied in the dorsal-plantar direction(as shown in FIG. 12A) or the plantar-dorsal direction (which wouldcause rotation in the opposite direction).

In some embodiments, the surgeon performs the osteotomy to separate thebone (e.g., first metatarsal) into a proximal section 410 and a distalsection 412. The surgeon drives a k-wire (not shown) transversely intothe distal section 412 of the bone. Then the surgeon passes the body 240over the k-wire, so the k-wire penetrates through the centrallongitudinal passage 242 (of body 240), and the threaded portion 244 ofthe body 240 threadably engages the distal fastener opening 134 of theimplant 100. The surgeon inserts a longitudinal k-wire (not shown) inthe proximal section 410 of the bone and uses a cannulated reamer (notshown) to form the longitudinal intramedullary opening 414 (FIG. 12B) inthe proximal section 410 concentric with the longitudinal k-wire. Thesurgeon removes the longitudinal k-wire from the longitudinalintramedullary opening 414 and inserts the intramedullary portion 110 ofthe implant 100 into the longitudinal intramedullary opening 414. Thesurgeon then applies the force F₁ or F₂ to cause the rotation throughthe angle 233 as shown in FIG. 12A.

During the rotation, the surgeon applies the force F₁ or F₂ to hollowcylinder 230, body 240 (or to drill 250 or k-wire 251), resulting inapplication of a moment M to rotate implant 100 and distal section 412of the bone about the longitudinal axis 120 of the intramedullaryportion 110 of implant 100. Although the surgeon can apply the force F₁or F₂ directly to the body 240, in some instances the surgeon may wishto grasp the hollow cylinder 230, drill 250 or k-wire 251, and use thehollow cylinder 230, drill 250 or k-wire 251 as a joy stick during therotation. The greater the moment arm MA, the smaller the force F₁ or F₂can be, and vice-versa. The surgeon applies the force F₁ or F₂ to rotateimplant 100 until the axis 231 of the body 240 rotates through a desiredangle 233, so the extramedullary portion 130 of the implant 100 anddistal bone section 412 are properly aligned with respect to theproximal section 410 of the bone. As shown in FIGS. 12A and 12B, whenthe extramedullary portion 130 is aligned with respect to the first bonesection 410, the extramedullary portion 130 applies the desiredcorrection (including rotation) to the second bone section 412.

The implant 100 can be provided with a variety of offsets 123 betweenthe first longitudinal axis 120 of the intramedullary portion 110 andthe second longitudinal axis 121 of the extramedullary portion 130. Theoffset 123 determines the translation applied to the second bone section412 relative to the first bone section 410. The surgeon can select theimplant 100 having an offset 123 that provides the desired translation.

FIG. 12B shows the target guide 200 after rotating the implant 100 andpositioning the distal bone section 412. In FIG. 12B, the target guide200 has a central longitudinal passage 242 (FIG. 11) penetrating thehollow cylinder 230. The central longitudinal passage 242 is adapted fortargeting the first cannulated drill 250 for drilling a distal hole 451(FIG. 13) in the distal bone section 412. The surgeon uses the drillguide 300 and a cannulated drill 350 to drill the inter-fragment hole453 (FIG. 13). The inter-fragment hole 453 passes through the proximalsection 410 of the bone and into the distal section 412 of the bone.Thus, a single target guide 200 can be used as a tool for positioningand rotating the implant 100 and distal section 412 relative to theproximal section 410, and as a guide for drilling the distal hole 451and the inter-fragment hole 453 to receive bone fasteners to maintainthe correct positions and alignment of the distal section 412.

The target guide described above is only exemplary and is not limiting.For example, in a variation of the target guide (not shown), the body240 is not pre-assembled within the hollow cylinder 230, and thepress-fit pin 245 is omitted. The surgeon or technician can assemble thebody 240 (or a drill guide, not shown, having the same outer diameter asbody 240) inside the hollow cylinder 230 before use. With a removablebody 240 or drill guide, the surgeon can remove the body 240 or drillguide and implant the distal fastener 452 (FIG. 13) through the hollowcylinder 230 of the target guide 200, without first removing the targetguide 200. This provides greater flexibility in surgical technique andprocedures.

FIG. 12C is a flow chart showing an example of a method for using thetarget guide.

At step 1200, the surgeon performs an osteotomy to separate a bone intoproximal and distal sections. For example, the surgeon can perform atransverse osteotomy to separate a first metatarsal into a proximalsection and a distal section. (The remainder of the description of FIG.12C refers to the bone as the first metatarsal of a foot, but this is anon-limiting example, and the method can be applied to other bones.)

At step 1202, the surgeon shifts one of the bone portions, so a nearestmedial edge of the distal section is offset from the first longitudinalaxis. For example, the surgeon can move the distal section of the firstmetatarsal in the lateral direction to expose at least a portion of thecut (anterior) surface of the proximal section of the first metatarsal.

At step 1204, the surgeon drives a k-wire in the longitudinal direction(referred to herein as the longitudinal k-wire) into the cut surface ofthe proximal section of the first metatarsal.

At step 1206, the surgeon uses a cannulated reamer to form thelongitudinal hole (for receiving the intramedullary portion of theimplant), while the k-wire is in the proximal section.

At step 1208, the surgeon removes the longitudinal k-wire from thelongitudinal intramedullary opening.

At step 1210, the surgeon attaches the target guide to the distalfastener opening in the extramedullary portion of the implant (byengaging the threaded end of the body of the target guide with thethreads of the distal fastener opening). Alternatively, the surgeon canobtain a pre-packaged or previously assembled construct comprising animplant attached to the threaded end of the body of a target guide. Thesurgeon inserts the intramedullary portion of the implant into thelongitudinal intramedullary opening in the proximal section of the firstmetatarsal. During the insertion, the surgeon may grip the body of thetarget guide to push the implant into the opening. When the insertion iscompleted, the extramedullary portion of the implant has a first sidefacing radially inward toward the first longitudinal axis of the implantand a second side facing radially outward from the first longitudinalaxis, where the second side has a concave surface that abuts a curvedbone surface of the distal section of the first metatarsal.

At step 1212, in some embodiments, the surgeon inserts a k-wire throughthe body of the target guide and drills the distal hole in the distalsection of the first metatarsal. In other embodiments, the surgeon omitsstep 1212.

At step 1214, the surgeon inserts a cannulated drill through the body ofthe target guide and drills the distal hole in the distal section of thefirst metatarsal, while the k-wire still is place.

At step 1216, after inserting the intramedullary portion into thelongitudinal hole, the surgeon applies a force to the target guide, adrill, or a k-wire to rotate the implant and the distal section of thefirst metatarsal about the first longitudinal axis in situ. The surgeonmay handle the drill or k-wire like a joy stick to manipulate and rotatethe implant and distal section of the first metatarsal. The surgeon usesthe drill or k-wire that defines the trajectory of the distal fasteneras a ‘joystick’ to find the optimum rotation angle (based on thelocation of the sesamoid bones of the first metatarsal, which thesurgeon can identify through fluoroscope, and to provide additionalcorrection of the intramedullary angle, IMA).

At step 1218, after applying the force to rotate the implant, thesurgeon drives an inter-fragment k-wire through the target guide, theproximal section of the first metatarsal, a first aperture in theintramedullary portion of the implant and into distal section of thefirst metatarsal.

At step 1220, the surgeon uses a cannulated drill to form theinter-fragment hole while the k-wire is in the distal section. Thesurgeon drills through the proximal section of the first metatarsal andthe first aperture of the implant, and into the distal section.

At step 1224, after forming the inter-fragment hole, the inter-fragmentk-wire is removed from the inter-fragment hole, and the surgeon insertsa nail, screw, k-wire or rod through the proximal section of the firstmetatarsal and the first aperture, and into the inter-fragment hole. Insome embodiments, the inter-fragment nail, screw, k-wire or rod has acannula, and the inserting step comprises inserting the inter-fragmentnail, screw, k-wire or rod in the inter-fragment hole with the k-wireextending through the cannula of the inter-fragment nail, screw, k-wireor rod.

At step 1226, the surgeon removes the distal k-wire from the distalhole, and then inserts the distal fastener (not shown in FIG. 12A)through the distal fastener aperture 134 and into the distal section412. A distal fastener (such as a locking or non-locking screw) isinserted through the distal aperture and into the distal section of thefirst metatarsal, to attach the extramedullary portion of the implant tothe distal section of the first metatarsal with a nearest medial edge ofthe distal section offset from the first longitudinal axis.

FIG. 13 shows the first metatarsal after completing the procedure shownin FIG. 12C. The implant system comprises the implant 100 and two ormore bone fasteners 450, 452 selected from nails, screws, k-wires, rodsor combinations thereof. The implant 100 has a unitary body includingthe intramedullary portion 110 connected to the extramedullary portion130. The unitary body is configured to attach a first bone section 110to a second bone section 112. The intramedullary portion 110 has a firstlongitudinal axis 120, and is configured for insertion into the firstbone section 110. The intramedullary portion 110 includes at least onefirst fastener aperture 112 having an aperture axis 122 orientedobliquely relative to the first longitudinal axis 120 and adapted toreceive the nail, screw, k-wire or rod 450. The extramedullary portion130 is configured to abut a surface of the second bone section 412 andincludes at least one second (distal) fastener aperture 134 disposed totransversely receive a bone fastener 452 inserted in the second bonesection 412. The extramedullary portion 130 has a second longitudinalaxis 121 parallel to, and offset from, the first longitudinal axis 120.Thus, the first longitudinal axis and a line between the respectivecenters of the two second fastener apertures 112, 134 form an obliqueangle.

The bone fasteners 450, 452 can include two or more nails, screws,k-wires or rods or combinations thereof. For example, the bone fasteners450, 452 can be selected from a cannulated screw, a lag screw, acompression screw, a locking screw, or a non-locking screw.

FIGS. 14-16 show an embodiment of an implant 1500 having two distalfastener apertures 1534 a, 1534 b to provide greater stability for thebone. The addition of a second distal screw offers an additional pointof fixation for severe hallux valgus or in the case of poor bonequality. In the case where the implant 1500 is substituted for implant100 in the FIG. 13, the second distal bone fastener prevents rotation ofthe distal section 412 of the first metatarsal in a sagittal plane(i.e., the implant 1500 prevents pitch motion).

The intramedullary portion 1510, second aperture 1512, taper 1514, andbevel 1516 can be the same as the respective intramedullary portion 110,second aperture 112, taper 114, and bevel 116 shown in FIGS. 1-3, andfor brevity, descriptions of these items are not repeated. Theextramedullary portion 1532 has a top surface 1536 and a bottom surface1538, which are analogous to the extramedullary portion 130, top surface136 and bottom surface 138 in FIGS. 1-3. However, extramedullary portion1532 has two distal apertures 1534 a and 1534 b. The two distalapertures 1534 a and 1534 b are aligned with each other and positionedon the axis of symmetry of the implant 1500. The axis of symmetryappears in FIG. 15 and coincides with section line 16-16.

The implants are not limited to one distal fastener 134 (as shown inFIGS. 1-3) or two distal fasteners 1534 a, 1534 b (as shown in FIGS.14-16). Other embodiments (not shown) can have more than two distalfasteners.

FIGS. 17-19 show another embodiment of the implant 1400 having twodistal fastener apertures 1434 a, 1434 b to provide greater stabilityfor the bone. Like the implant 1500 of FIGS. 14-16, the implant 1400 hastwo distal bone fasteners 1434 a, 1434 b to prevent rotation of thedistal section 412 of the first metatarsal in the sagittal plane.

The intramedullary portion 1410, second aperture 1412, taper 1414, bevel1416, extramedullary portion 1432 fastener apertures 1434 a, 1434 b, topsurface 1436 and bottom surface 1438 of FIGS. 17-19 can be the same asthe respective intramedullary portion 1510, second aperture 1512, taper1514, bevel 1516, extramedullary portion 1532 fastener apertures 1534 a,1534 b, top surface 1536 and bottom surface 1538, shown in FIGS. 14-16,and for brevity, descriptions of these items are not repeated.

However, in the example of FIGS. 17-19, the intramedullary portion 1410has a cannula 1450 extending from the bevel 1416 to the proximal end1462 of the implant 1400. The cannula 1450 allows insertion of thelongitudinal k-wire through the central longitudinal axis 1420 of theimplant 1400, so the implant 1400 is guided into place by the k-wire.

Implant 1400 also has a longitudinal slot 1460 passing through thecentral axis 1420 of the intramedullary portion 1410. The slot 1460 canextend from the proximal end 1462 (opposite from the extramedullaryportion 1432) of the implant 1400, at least as far as the at least onefirst fastener aperture 1412. For example, in some embodiments, the slot1460 extends from the proximal end 1462 to a termination 1464, where thetermination 1464 is between the second aperture 1412 and the bevel 1416.The slot 1460 provides compression within the intramedullary canal, tohelp stabilize the intramedullary portion 1410. In some embodiments, theslot 1460 contains a biologic material. In some embodiments, thebiologic material can be a combination of Medical grade β-TCP granulesand rhPDGF-BB solution, such as “AUGMENT®” bone graft material sold byWright Medical Technology, Inc. of Memphis, Tenn. In some embodiments,the biologic material can be a coating containing osteoinductive orosteoconductive biological components. The biologic material can includebone morphogenetic factors, i.e., growth factors whose activity arespecific to bone tissue including, but not limited to, demineralizedbone matrix (DBM), bone protein (BP), bone morphogenetic protein (BMP),and mixtures and combinations thereof. The slot 1460 also allowsingrowth of bone from dorsal and plantar directions. Additionally,formulations for promoting the attachment of endogenous bone maycomprise bone marrow aspirate, bone marrow concentrate, and mixtures andcombinations thereof

In some embodiments, the longitudinal slot 1460 completely penetratesthe intramedullary portion 1410, from the plantar side 1480 to thedorsal side 1481. The slot 1460 divides the cross section of theintramedullary portion 1410 into two approximately semicircularportions.

Also, extramedullary portion 1432 has two alignment apertures 1470 a,1470 b, which are separate from the fastener apertures 1434 a, 1434 b,and into which pins or wires can be placed. The two distal apertures1534 a and 1534 b are aligned with each other and positioned on the axisof symmetry of the implant 1500. The axis of symmetry appears in FIG. 15and coincides with section line 16-16.

Although the implant 1400 includes the cannula 1450, the slot 1460 andthe alignment apertures 1470 a, 1470 b, other embodiments may includeany one, any two, or all three of these features.

FIGS. 20-22 show another embodiment of the implant 1800 having offsetdistal fastener apertures 1834 a, 1834 b. Like the implant 1500 of FIGS.14-16, the implant 1800 has two distal bone fasteners 1834 a, 1834 b toprevent rotation of the distal section 412 of the first metatarsal inthe sagittal plane.

The intramedullary portion 1810, second aperture 1812, taper 1814, andbevel 1816 of FIGS. 20-22 can be the same as the respectiveintramedullary portion 1510, second aperture 1512, taper 1514, and bevel1516 of FIGS. 14-16, and for brevity, descriptions of these items arenot repeated. The extramedullary portion 1832, fastener apertures 1834a, 1834 b, top surface 1836 and bottom surface 1838 of implant 1800 areanalogous to the corresponding extramedullary portion 1532, fastenerapertures 1534 a, 1534 b, top surface 1536 and bottom surface 1538,shown in FIGS. 14-16.

However, at least one of the two second fastener apertures 1834 a, 1834b has a center that is offset from the central longitudinal axis 1820(which lies along the section line 22-22 and is shown in FIG. 22. Forexample, in FIG. 21, the implant 1800 has two distal fastener apertures1834 a and 1834 b, both of which are offset from the centrallongitudinal axis 1820. In some embodiments, the centers of fastenerapertures 1834 a and 1834 b both have the same distance from the centrallongitudinal axis 1820, but are arranged on opposite sides of thecentral longitudinal axis 1820. A line 1882 connecting the centers offastener apertures 1834 a and 1834 b forms an angle 1880 with thecentral longitudinal axis 1820. In various embodiments, the angle 1882can be varied to accommodate different shapes and positions of thedistal section 412 of the first metatarsal. The offset configurationalso allows the surgeon to position the fastener apertures 1834 a and1834 b adjacent to the regions of the distal section 412 having the bestbone quality.

In other embodiments, the number of distal fastener apertures and theirpositions can be varied.

FIGS. 23-25 show another example of the implant 2300. The implant 2300is configured to impart a lateral angular correction, to correct amedial deviation of the distal portion of the bone (e.g., metatarsal).Like the implant 100 of FIG. 1, implant 2300 includes an extramedullaryportion 2330 that is offset from the central longitudinal axis of theintramedullary portion. Additionally, the extramedullary portion 2330has an offset angle θ (relative to the central longitudinal axis 2320 ofthe intramedullary portion 2310), shown in FIG. 25, for making thelateral angular correction. FIG. 23 is a lateral view of the implant2300. FIG. 24 is a superior view of the implant 2300 of FIG. 23. FIG. 25is a cross-sectional view of the implant 2300 of FIG. 23, taken alongsection line 25-25. FIG. 30 is a schematic diagram showing the implant2300 in situ after insertion in the foot 400 of a patient—FIG. 30 alsoshows the broach 2600 (in phantom), superimposed on the implant 2300;the broach 2600 is used to form the intramedullary opening to receiveimplant 2300.

Referring to FIGS. 23-25, the implant 2300 has a unitary body includingan intramedullary portion 2310 connected to an extramedullary portion2330. The unitary body of implant 2300 is configured to attach a firstbone section 410 (FIG. 13) to a second bone section 412 (FIG. 13).

The intramedullary portion 2310 can have the same size and shape as theintramedullary portion 110 of the implant 100 of FIG. 1. Theintramedullary portion 2310 has a first longitudinal axis 2320, whichcan be a central axis. The intramedullary portion 2310 is configured forinsertion into the first bone section 410 (FIG. 30). The intramedullaryportion 2310 includes at least one first fastener aperture 2312 havingan aperture axis 2322. The aperture axis 2322 is oriented obliquelyrelative to the first longitudinal axis 120. For example, the apertureaxis 2322 can be 45 degrees from the first longitudinal axis 2320. Theat least one first fastener aperture 2312 is configured to receive ascrew, k-wire or rod extending therethrough.

In some embodiments, the intramedullary portion 2310 has a taperedproximal end 2314. The tapered proximal end 2314 facilitates insertionof the implant 2300 into a longitudinal hole in the first (proximal)section 410 of the bone. The intramedullary portion 2310 can also have abeveled distal end 2316 to provide a smoother transition between thefirst bone section 410 (FIG. 13) and the second bone section 412 (FIG.13).

The extramedullary portion 2330 is configured to abut a surface of thesecond bone section 412 (FIG. 13). The extramedullary portion 2330includes at least one second (distal) fastener aperture 2334 disposed toreceive a bone fastener 452 inserted in the second bone section 412. Thebone fastener 452 may be disposed transversely or obliquely, relative tothe fastener aperture 2334. In some embodiments, polyaxial screws can beinserted with an angle of 0.0 to about 15 degrees from the transverseaxis of the second (distal) fastener aperture 2334. The extramedullaryportion 2330 has a second longitudinal axis 2321. The secondlongitudinal axis 2321 is oriented at an offset angle θ from, the firstlongitudinal axis 2320. For example, the offset angle θ can be about 15degrees (e.g., from 10 degrees to 20 degrees).

The extramedullary portion 2330 has a first side 136 facing radiallyinward (opposite the radial direction R) toward the first longitudinalaxis 120 and a second side 2338 facing radially outward (in the radialdirection R) away from the first longitudinal axis 120. In someembodiments, the second side 2338 has a concave surface adapted toengage a curved bone surface 413 (e.g., the medial surface of the distalportion of the first metatarsal). In other embodiments, the second side2338 can be flat.

In some embodiments, the extramedullary portion 2330 has a taperedportion 2339 from the distal end of the beveled distal end 2316 to theproximal end of the fastener aperture 2334. The tapered portion 2339 canhave a curved profile or a linear profile.

The implant 2300 can comprise any of the materials discussed above inthe description of implant 100 of FIGS. 1-3. The description of thesematerials is not repeated, solely for brevity.

Like the implant 100 (FIGS. 1-3), the implant 2300 can be provided witha variety of offsets between the first longitudinal axis 2320 of theintramedullary portion 2310 and the second longitudinal axis 2321 of theextramedullary portion 2330. The surgeon selects the implant 2300 havingthe desired offset to achieve the appropriate translation for correctingthe hallux valgus deformity.

In some embodiments, the intramedullary portion 2310 can be cannulatedto be placed over a guide wire (not shown). During the surgery, theguide wire is driven into the cut surface of the proximal bone fragmentand on the medial surface of the translated (distal) fragment.

FIGS. 26-30 show a broach 2600 for forming the longitudinal opening inthe proximal portion of the bone, such that the opening is adapted toreceive the intramedullary portion of the implant 2300. FIG. 26 is aplan view of the broach 2600. FIG. 27 is a cross section of the broach2600, taken along section line 27-27 of FIG. 26. FIG. 28A is an enlargeddetail of FIG. 27.

The broach 2600 includes a handle 2614 and a blade 2610. The blade 2610has a cross section with the same shape as the cross section of theintramedullary portion 2310 of the implant 2300. The blade 2610 is sizedslightly (e.g., 0.001 inch) larger than the intramedullary portion 2310,so as to snugly receive the intramedullary portion 2310. For example,the intramedullary portion 2310 and blade 2610 can both be cylindrical.In one example, the intramedullary portion 2310 of the implant 2300 hasa diameter of 0.252, and the blade 2610 of the broach 2600 has adiameter 2611 of 0.254. In other embodiments (not shown), theintramedullary portion 2310 and blade 2610 can both have another shapesuch as, but not limited to, a square.

The blade 2610 has a tapered chisel-end 2602, which can include a firsttapered portion 2604, a flat portion 2606 and a second tapered portion2608. As best seen in the embodiment of FIG. 27, the first taperedportion 2604 and the flat portion 2606 form a relatively narrow tip,similar to a flat-head screw driver, and the second tapered portion 2604provides a smooth transition between the cylindrical blade 2610 and theflat portion 2606. In FIGS. 26-28A, the first tapered portion 2604 andthe second tapered portion 2608 have planar surfaces for a linear taper.In other embodiments (not shown), the first tapered portion 2604 and thesecond tapered portion 2608 have curved surfaces.

The broach 2300 has an alignment feature, such as a notch 2612 orindicia (not shown), to assist in targeting a screw or nail. Forexample, in FIGS. 27 and 28A, a notch 2612 with a reference surface 2613is provided. During a hallux valgus correction procedure, the surgeoncan align a radiopaque elongated member (e.g., a k-wire or olive wire,not shown) with the reference surface 2613 under fluoroscopy. Thereference surface 2613 and/or k-wire aligned with the reference surface2613 can identify the axis for positioning a cross-screw (not shown)that enters the proximal portion of the bone, the aperture 2312, and thedistal portion of the bone, as shown in FIGS. 29 and 30.

The broach 2600 has an abutting surface 2640 oriented at an angle θrelative to the longitudinal axis 2620 of the broach. The angle θ inbroach 2600 can be the same as the angle θ between the longitudinal axis2320 of the intramedullary portion 2310 and the axis 2321 of theextramedullary portion 2330 of the implant 2300. This allows the surgeonto use the broach 2600 to position the distal portion of the metatarsaland drill the opening for the cross-screw. The surgeon can position thedistal portion of the metatarsal against the surface 2640 of the broachand drill the hole for the cross-screw. Subsequently, when the broach2600 is removed, and the implant 2300 substituted for the broach 2600,the surface 2338 of the implant 2300 abuts the medial side of the distalportion of the metatarsal, and the aperture 2312 of the implant 2300 isaligned with the cross-screw openings in the proximal and distalportions of the metatarsal. FIGS. 29 and 30 best show the relationshipsbetween surfaces of the implant 2300 and the broach 2600.

FIG. 31 shows a variation of the target guide 200 of FIG. 12B. FIG. 31is a plantar view of the target guide 3100. A single target guide 3100can be used for treating hallux valgus in both right feet and left feet.FIG. 31 shows the target guide 3100 in use on a left foot 400, with theside 201 facing in the dorsal direction. When the target guide 3100 isused for treating the right foot (not shown), the target guide 3100 isflipped over, so that the side of the target guide 3100 opposite side3101 becomes the dorsal side, and the side 3101 shown in FIG. 31 becomesthe plantar side.

The target guide 3100 of FIG. 3100 comprises an arm 3110 extending froma hollow cylinder 3130. The arm 3110 has a guide aperture 3114penetrating the arm 3110 and adapted for targeting a second drill 350for drilling a hole (inter-fragment hole) through a proximal bonesection 410 and into the distal bone section 412. In some embodiments,the guide aperture 3114 is configured to receive the drill guide 300 ofFIGS. 10 and 11, described above.

The body 3140 has a first longitudinal axis 3131, and the guide aperture3114 of the arm 3110 of target guide 3100 has a second longitudinal axis3115. The arm 3110 has a third longitudinal axis 3117, such that a plane(not shown) passes through the first longitudinal axis 3131, secondlongitudinal axis 3115, and third longitudinal axis 3117. The distalfastener aperture 2334 of the extramedullary portion 2330 of implant2300 penetrates an interface surface of the extramedullary portion 2330of the implant 2300. When the body 3140 engages the distal fasteneraperture 2334 of the implant 2300, the longitudinal axis 3131 of thebody 3140 is normal to the interface surface and axis 2321 of theextramedullary portion 2330.

FIG. 31 shows the drill guide 300 in situ in the target guide 3100. Thearm 3110 can have a window 3160 extending from the medial surface of thearm to the lateral surface of the arm. The surgeon can insert a cuttingtool (e.g., a beaver blade) through the window 3160 of the arm 3110 tomake an incision in the patient's skin.

The target guide 3100 has a collet 3150 which tightens the grip of thethreaded tube portion 3152 about the drill guide 300. The collet 3150allows adjustment of the longitudinal position of the drill guide 300within the target guide (for example, to accommodate different offsetsbetween the distal portion 412 of the bone and the proximal portion 410of the bone. The collet 3150 can hold the drill guide 300 in place, evenin longitudinal positions where the head 3122 of the drill guide doesnot abut the collet 3150. To provide a compression fitting function, thethreaded tube portion 3152 can have a tapered profile (not shown) withlongitudinal slots (not shown) at the end of the threaded tube portion3152. In other embodiments, the collet 3150 can have a compression ring(not shown) for gripping the drill guide 300.

The target guide 3100 can be used as a tool to position and rotate theimplant 2300 and the second (distal) section 412 of the bone (e.g.,first metatarsal) about the first longitudinal axis 2320 of implant 100in situ, after the intramedullary portion 2310 of implant 2300 isinserted in a longitudinal intramedullary hole 3114 in the proximalsection 410 of the bone.

In other respects, the operation of target guide 3100 is the same asdescribed above with respect to the target guide 200 of FIG. 12B.

FIG. 32 is a flow chart of a method of using the implant 2300 of FIGS.23-25, the broach 2600 of FIGS. 26-30 and the targeting guide 3100 ofFIG. 31.

At step 3200, the surgeon cuts an osteotomy (e.g., in the firstmetatarsal) using a cutting tool, such as a burr.

At step 3202, the surgeon translates the distal fragment 412 of themetatarsal laterally relative to the proximal fragment 410 of themetatarsal, using a tool such as a curved elevator, for example.

At step 3204, the surgeon inserts the broach 2600 into the metatarsalcanal of the proximal fragment 410 of the metatarsal, as shown in FIG.29. The position of the distal fragment 412 can be adjusted, so thedistal fragment 412 contacts the abutting surface 2640 of broach 2600.With the distal fragment 412 properly positioned, the broach 2600 can beremoved from the proximal fragment.

At step 3206, the implant 2300 is attached to the targeting guide 3100.The implant 2300 is then inserted into the metatarsal canal into theposition previously occupied by the broach 2600, as shown in FIG. 30.(In FIG. 30, the broach 2600 is shown in phantom.) Thus positioned, theplate portion 2330 of implant 2300 contacts the medial surface of thedistal fragment 412.

At step 3208, the surgeon drills the distal hole in the distal fragment412 to receive the distal screw. If the surgeon wishes to rotate thedistal fragment 412 relative to the proximal fragment, the surgeon canuse the guide 3100 and/or the drill 250 as a joystick for rotating thedistal fragment 412.

At step 3210, the surgeon inserts the drill sleeve 3122 for theinter-fragment hole into the targeting guide 3100. The surgeonidentifies the drill's insertion point into the bone and creates anincision in the patient's skin using a blade (e.g., a beaver blade, notshown) inserted through the window 3160 extending from the medialsurface of the arm 3110 to the lateral surface of the arm 3110.

At step 3212, the surgeon continues to insert the drill sleeve 3122through the arm 3110 until the tip of the sleeve 3122 contacts the outersurface of the proximal fragment 410 of the metatarsal, as shown in FIG.31. The surgeon tightens the collet 3150 around the threaded tubeportion 3152 to lock the drill sleeve 3122 in place.

At step 3214, guided by fluoroscopy, the surgeon drills theinter-fragment pilot hole through the proximal fragment 410 and distalfragment 412.

At step 3216, the surgeon removes the drill 350 from the inter-fragmentpilot hole, inserts a k-wire, olive wire or the like (not shown) intothe inter-fragment pilot hole, unlocks the collet 3150, and removes thedrill sleeve 3122 from the targeting guide 3100. The k-wire or olivewire maintains the relative positions of the proximal and distalfragments 410, 412.

At step 3218, using a depth guide (not shown) and the k-wire or olivewire, the surgeon identifies the appropriate inter-fragment screw lengthto insert into the inter-fragment pilot hole.

At step 3220, the surgeon removes the depth gage and inserts theinter-fragment screw 450 (which can be the same as the screw 450 in FIG.13) over the k-wire.

At step 3222, the surgeon removes the targeting guide 3100 and thedistal drill 250, and inserts the distal screw 452 (which can be alocking screw 452 as shown in FIG. 13).

Although the examples of intramedullary portions 110, 1410, 1510, 1810and 2310 of respective implants 100, 1400, 1500, 1800 and 2300 are shownas having circular cross-sections, any of the intramedullary portions110, 1410, 1510, 1810 and 2310 can have a different cross-sectionalshape, such as an ellipse, a triangle, a rectangle, or other polygon.Any of these embodiments can be implemented with our without a slot(FIG. 17) or longitudinal cannula (not shown).

The implant 100 or 2300 is inserted using the targeting guide 300 or3100, and its position and rotation angle are maintained by a screw 450(FIG. 12B). In other embodiments (not shown), the intramedullary portionis expandable. For example, the intramedullary portion can have anexpandable (e.g., flared) portion and an expander (e.g., cone) portionthat radially expands the expandable portion when the expandable andexpander portions are driven together. Alternatively, the intramedullaryportion can have a molly bolt mechanism. In other embodiments, theexpansion is provided by phase change of a shape-memory material, suchas nitinol.

Although the subject matter has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodiments,which may be made by those skilled in the art.

What is claimed is:
 1. An implant comprising: a unitary body includingan intramedullary portion connected to an extramedullary portion, theunitary body configured to attach a first bone section to a second bonesection; the intramedullary portion having a first longitudinal axis,and being configured for insertion into the first bone section, theintramedullary portion including at least one first fastener aperturehaving an aperture axis oriented obliquely relative to the firstlongitudinal axis; and the extramedullary portion configured to abut asurface of the second bone section and including at least one secondfastener aperture disposed to transversely receive a bone fastenerinserted in the second bone section, the extramedullary portion having asecond longitudinal axis offset from the first longitudinal axis.
 2. Theimplant of claim 1, wherein the at least one first fastener aperture isconfigured to receive a nail, screw, k-wire or rod extendingtherethrough.
 3. The implant of claim 1, wherein the extramedullaryportion has a first side facing radially inward toward the firstlongitudinal axis and one second side facing radially outward from thefirst longitudinal axis, the second side having a concave surfaceadapted to engage a curved bone surface.
 4. The implant of claim 3wherein the intramedullary portion comprises a shaft having an outersurface, and the extramedullary portion is joined to the intramedullaryportion so that a portion of the outer surface is located between thefirst side of the extramedullary portion and the second side of theextramedullary portion.
 5. The implant of claim 1, wherein the at leastone second fastener aperture is adapted to receive a locking fastener.6. The implant of claim 1, wherein the at least one second fasteneraperture includes two second fastener apertures.
 7. The implant of claim6, wherein at least one of the two second fastener apertures have acenter that is offset from the second longitudinal axis.
 8. The implantof claim 1, wherein the second longitudinal axis and the firstlongitudinal axis form an oblique angle.
 9. The implant of claim 1,wherein the intramedullary portion has a cannula.
 10. The implant ofclaim 1, wherein: the first longitudinal axis is a central axis, and theintramedullary portion has a proximal end opposite from theextramedullary portion, and a slot passing through the central axis ofthe intramedullary portion, the slot extending from the proximal end atleast to the at least one first fastener aperture.
 11. An implantsystem, comprising: a nail, screw, k-wire or rod; and an implantcomprising: a unitary body including an intramedullary portion connectedto an extramedullary portion, the unitary body configured to attach afirst bone section to a second bone section; the intramedullary portionhaving a first longitudinal axis, and being configured for insertioninto the first bone section, the intramedullary portion including atleast one first fastener aperture having an aperture axis orientedobliquely relative to the first longitudinal axis and adapted to receivethe nail, screw, k-wire or rod; and the extramedullary portionconfigured to abut a surface of the second bone section and including atleast one second fastener aperture disposed to transversely receive abone fastener inserted in the second bone section, the extramedullaryportion having a second longitudinal axis offset from the firstlongitudinal axis.
 12. The implant system of claim 11, wherein the nail,screw, k-wire or rod is selected from the group consisting of acannulated screw, a lag screw, a compression screw, a locking screw, anda non-locking screw.
 13. The implant system of claim 11, furthercomprising a target guide having a threaded portion adapted to engagethe second fastener aperture, the target guide having a body adapted toextend from the extramedullary portion when the threaded portion engagesthe second fastener aperture, the target guide having a centrallongitudinal passage penetrating the body and adapted for targeting adrill for drilling a hole in the second bone section.
 14. The implantsystem of claim 13, wherein the target guide is adapted to apply amoment to the implant when a force is applied to the body.
 15. A methodof treating a hallux valgus, comprising: performing an osteotomy in abone to separate a distal section of the bone from a proximal section ofthe bone; forming a longitudinal hole in the proximal section of thebone; inserting an intramedullary portion of an implant into thelongitudinal hole, the intramedullary portion having a firstlongitudinal axis and a first aperture, the first aperture having anaperture axis oriented at an oblique angle with respect to the firstlongitudinal axis, the implant having an extramedullary portionconnected to the intramedullary portion, the extramedullary portionhaving a second longitudinal axis offset from the first longitudinalaxis, the extramedullary portion having at least one distal aperture;drilling an inter-fragment hole, through the proximal section and thefirst aperture, and into the distal section; inserting a fastenerthrough the distal aperture and into the distal section to attach theextramedullary portion to the distal section with a nearest medial edgeof the distal section offset from the first longitudinal axis; andinserting a nail, screw, k-wire or rod through the proximal section andthe first aperture, and into the inter-fragment hole.
 16. The method ofclaim 15, wherein the bone is a metatarsal of a foot.
 17. The method ofclaim 15, wherein the extramedullary portion has a first side facingradially inward toward the first longitudinal axis and a second sidefacing radially outward from the first longitudinal axis, the secondside having a concave surface that abuts a curved bone surface of thedistal section when the fastener is inserted.
 18. The method of claim 15wherein the intramedullary portion comprises a cylinder having an outersurface, and the extramedullary portion is joined to the intramedullaryportion so that a portion of the outer surface is located between thefirst side of the extramedullary portion and the second side of theextramedullary portion.
 19. The method of claim 15, further comprisingattaching a target guide to the extramedullary portion; and applying aforce to the target guide, or a drill or k-wire extending from thetarget guide, to rotate the implant and the distal section about thefirst longitudinal axis after inserting the intramedullary portion intothe longitudinal hole.
 20. The method of claim 19, further comprisingdrilling a hole through the target guide and into the distal section ofthe bone before applying the force to rotate the implant and the distalsection.
 21. The method of claim 19, wherein drilling the inter-fragmenthole is performed after applying the force to rotate the implant and thedistal section.
 22. The method of claim 15, wherein drilling theinter-fragment hole comprises: driving a k-wire through the proximalsection and the first aperture, and into the distal section; and using acannulated drill to form the inter-fragment hole while the k-wire is inthe distal section.
 23. The method of claim 22, further comprisingremoving the k-wire from the inter-fragment hole after the forming. 24.The method of claim 22, wherein the inter-fragment nail, screw, k-wireor rod has a cannula, and the inserting step comprises inserting theinter-fragment nail, screw, k-wire or rod in the inter-fragment holewith the k-wire extending through the cannula of the inter-fragmentnail, screw, k-wire or rod.
 25. The method of claim 15, wherein formingthe longitudinal hole includes: driving a k-wire into the proximalsection; and using a cannulated reamer to form the longitudinal holewhile the k-wire is in the proximal section.
 26. A target guide,comprising: a threaded portion adapted to engage a fastener aperture ofan implant having an implant longitudinal axis; a body movable with thethreaded portion, the body adapted to extend from a portion of theimplant defining the fastener aperture when the threaded portion engagesthe fastener aperture, wherein the target guide is adapted to apply amoment to rotate the implant around the implant longitudinal axis when aforce is applied to the body, or a k-wire or drill extending from thebody; the target guide having a passage penetrating the body and adaptedfor targeting a first drill for drilling a hole in a first bone section.27. The target guide of claim 26, further comprising an arm extendingfrom the body, the arm having a guide aperture penetrating the arm andadapted for targeting a second drill for drilling a second hole througha second bone section and into the first bone section.
 28. The targetguide of claim 27, wherein the body has a first longitudinal axis, andthe guide aperture has a second longitudinal axis, and the arm has athird longitudinal axis, such that a plane passes through the first,second and third longitudinal axes.
 29. The target guide of claim 27,wherein the first longitudinal axis of the body is normal to aninterface surface of an extramedullary portion of the implant, where thefastener aperture penetrates the interface surface.
 30. An implantsystem, comprising: a nail, screw, k-wire or rod; an implant comprising:a unitary body including an intramedullary portion connected to anextramedullary portion, the unitary body configured to attach a firstbone section to a second bone section; the intramedullary portion havinga first longitudinal axis, and being configured for insertion into thefirst bone section, the intramedullary portion including at least onefirst fastener aperture having an aperture axis oriented obliquelyrelative to the first longitudinal axis and adapted to receive the nail,screw, k-wire or rod; and the extramedullary portion configured to abuta surface of the second bone section and including at least one secondfastener aperture disposed to transversely receive a bone fastenerinserted in the second bone section, the extramedullary portion having asecond longitudinal axis offset from the first longitudinal axis; and atarget guide having a threaded portion adapted to engage the secondfastener aperture, the target guide having a body adapted to extend fromthe extramedullary portion when the threaded portion engages the secondfastener aperture, the target guide having a central longitudinalpassage penetrating the body and adapted for targeting a drill fordrilling a hole in the second bone section.
 31. The system of claim 30,wherein the nail, screw, k-wire or rod comprises at least one polyaxialscrew.
 32. The system of claim 30, further comprising a broachconfigured to form an opening in the first bone section for receivingthe intramedullary portion, the broach having an alignment feature foraligning an inter-fragment hole in the first bone section and secondbone section.